Clevudine was approved as an
antiviral agent for hepatitis B virus, which showed marked, rapid inhibition of virus replication without significant toxicity. However, several studies have reported
myopathy associated with
clevudine therapy. Also, we experienced seven patients who suffered from
myopathy during
clevudine therapy. To characterize
clevudine-induced
myopathy, we collected previously reported cases of
clevudine myopathy and analyzed all the cases including our cases. We searched electronic databases that were published in English or Korean using PubMed and KoreaMed. Ninety-five cases with
clevudine myopathy, including our seven cases, were selected and analyzed for the demographic data, clinical features, and pathologic findings. The 95 patients with
clevudine-induced
myopathy comprised 52 women and 43 men aged 48.9 years (27-76 years). The patients received
clevudine therapy for about 14.2 months (5-24 months) before the development of symptoms. Weakness mainly involved proximal extremities, especially in the lower extremities, and bulbar and neck weakness were observed in some cases (13.7%).
Creatine kinase was elevated in the majority of patients (97.9%). Myopathic patterns on electromyography were observed in most patients examined (98.1%). Muscle biopsy presented patterns compatible with
mitochondrial myopathy in the majority (90.2%). The weakness usually improved within about 3 months after the discontinuation of
clevudine. Though
clevudine has been known to be safe in a 6-month clinical trial, longer
clevudine therapy for about 14 months may cause reversible
mitochondrial myopathy. Careful clinical attention should be paid to patients with long-term
clevudine therapy.